Full Text View
Tabular View
No Study Results Posted
Related Studies
Irinotecan in Treating Aging Patients With Solid Tumors
This study has been completed.
Study NCT00026195   Information provided by National Cancer Institute (NCI)
First Received: November 9, 2001   Last Updated: July 23, 2008   History of Changes

November 9, 2001
July 23, 2008
September 2001
 
 
 
Complete list of historical versions of study NCT00026195 on ClinicalTrials.gov Archive Site
 
 
 
Irinotecan in Treating Aging Patients With Solid Tumors
Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Aging may affect the way these drugs work.

PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of irinotecan in treating patients who have solid tumors.

OBJECTIVES:

  • Determine whether there is a relationship between the pharmacokinetic characteristics of irinotecan and aging in patients with non-hematologic malignancies.
  • Determine whether there is a relationship between the toxic effects of this drug and aging in these patients.
  • Determine whether the relationship between genotype (UGT1A1, CYP3A, and other relevant genes) and phenotype (pharmacokinetics, toxicity) is affected by aging in these patients treated with this drug.
  • Analyze data collected on the co-morbid conditions and concurrent medications in these patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to age (18 to 55 vs 70 and over).

Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 140 patients (70 per stratum) will be accrued for this study within 3.5 years.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-hematologic malignancy
  • Brain metastases or primary brain tumors are eligible provided patient is not receiving steroids or antiepileptic medications

PATIENT CHARACTERISTICS:

Age:

  • 18 to 55 or 70 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT no greater than ULN

Renal:

  • Creatinine no greater than ULN

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)
  • No more than 1 prior chemotherapy regimen for metastatic disease (no limit if administered in the adjuvant setting)
  • No prior camptothecin

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy, including for palliation

Surgery:

  • At least 4 weeks since prior major surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00026195
 
CDR0000068995, CLB-60001
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Stuart M. Lichtman, MD Don Monti Comprehensive Cancer Center at North Shore University Hospital
National Cancer Institute (NCI)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP